Reference : Risk-Based Approach for the Transfer of Quantitative Methods: Bioanalytical Applications
Scientific journals : Article
Human health sciences : Pharmacy, pharmacology & toxicology
http://hdl.handle.net/2268/1817
Risk-Based Approach for the Transfer of Quantitative Methods: Bioanalytical Applications
English
Rozet, Eric mailto [Université de Liège - ULg > > Chimie analytique >]
Dewé, Walthère [Université de Liège - ULg > > Analyse des médicaments >]
Morello, R. [> > > >]
Chiap, Patrice mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Lecomte, Frédéric mailto [Université de Liège - ULg > > Chimie analytique >]
Ziemons, Eric mailto [Université de Liège - ULg > > Chimie analytique >]
Boos, K. S. [> > > >]
Boulanger, Bruno [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Crommen, Jacques mailto [Université de Liège - ULg > Département de pharmacie > Analyse des médicaments >]
Hubert, Philippe mailto [Université de Liège - ULg > > Chimie analytique >]
2008
Journal of Chromatography. A
1189
32-41
Yes (verified by ORBi)
International
0021-9673
[en] The transfer of analytical methods from a sending laboratory to a receiving one requires to guarantee that this last laboratory will obtain accurate results. Undeniably method transfer is the ultimate step before routine implementation of the method at the receiving site. The conventional statistical approaches generally used in this domain which analyze separately the trueness and precision characteristics of the receiver do not achieve this. Therefore, this paper aims first at demonstrating the applicability of two recent statistical approaches using total error-based criterion and taking into account the uncertainty of the true value estimate of the sending laboratory, to the transfer of bioanalytical methods. To achieve this, they were successfully applied to the transfer of two fully automated liquid chromatographic method coupled on-line to solid-phase extraction. The first one was dedicated to the determination of three catecholamines in human urine using electrochemical detection, and the second one to the quantitation of N-methyl-laudanosine in plasma using fluorescence detection. Secondly, a risk-based evaluation is made in order to understand why classical statistical approaches are not sufficient to provide the guarantees that the analytical method will give most of the time accurate results during its routine use. Finally, some recommendations for the transfer studies are proposed.
Researchers ; Professionals ; Students
http://hdl.handle.net/2268/1817
10.1016/j.chroma.2007.11.029

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